CN101010112B - Medical device adapted for detection of drug condition - Google Patents

Medical device adapted for detection of drug condition Download PDF

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Publication number
CN101010112B
CN101010112B CN 200580029490 CN200580029490A CN101010112B CN 101010112 B CN101010112 B CN 101010112B CN 200580029490 CN200580029490 CN 200580029490 CN 200580029490 A CN200580029490 A CN 200580029490A CN 101010112 B CN101010112 B CN 101010112B
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light
storage chamber
delivery device
drug
drug delivery
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CN 200580029490
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Chinese (zh)
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CN101010112A (en
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J·S·尼尔森
P·E·埃尔加德彼得森
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诺和诺德公司
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Priority to DKPA200401327 priority
Priority to DKPA200401327 priority
Priority to DKPA200401328 priority
Application filed by 诺和诺德公司 filed Critical 诺和诺德公司
Priority to PCT/EP2005/054294 priority patent/WO2006024650A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/51Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587Lighting arrangements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/53Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke
    • G01N21/532Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke with measurement of scattering and transmission

Abstract

A drug delivery device is provided, comprising a reservoir adapted to contain a liquid drug, an outlet, and expelling means for, in a situation of use, expelling a drug from the reservoir via the outlet. The device further comprises a light source adapted for directing a beam of light through the drug, and detection means allowing a transmission characteristic of the light beam through the drug tobe detected. The detecting means may be either in form of a transparent area allowing a user to inspect a portion of the device through which the light beam is directed, or light detection means usedin combination with an electronic controller.

Description

适于检测药物状态的医用卫生器材 Adapted to detect the state of medical drugs and health equipment

技术领域 FIELD

[0001] 本发明通常涉及一种药物输送设备,该药物输送设备包括用于检查待输送药物状态的装置,该药物状态特别是胰岛素的原纤维化(fibrillation),但不限于此。 [0001] The present invention generally relates to fibrillation (fibrillation with) a drug delivery device, a drug to be delivered state inspection apparatus of the drug delivery device comprising means for, in particular, the state of insulin medication, but is not limited thereto.

背景技术 Background technique

[0002] 在本发明参考文献的披露内容中,大部分都是通过注射或输注胰岛素来治疗糖尿病,然而,这只是本发明的一个示范性应用。 [0002] In the disclosure of the present invention, references, mostly for the treatment of diabetes by injection or infusion of insulin, however, this is only one exemplary application of the invention.

[0003] 用于向病人输送药物的便携式药物输送设备是众所周知的,并且其通常包括适于包含液体药物的储存室并具有与中空输注针流体连通的出口,以及排出装置,以将药物排出储存室并经由中空针穿过注射对象的皮肤。 [0003] The portable medicament for delivering a drug delivery device to a patient are well known, and generally includes a storage chamber adapted to contain a liquid drug and having an outlet in fluid communication with a hollow infusion needle, and a discharging means for discharging the medicament storage chamber and through the skin via the hollow needle is the injection target. 输送设备可适用于不连续的使用,即,在一天中按规定次数注射定量的药物,或者其适于通过输送设备和病人之间的永久流体连通连续或者类似地连续输送药物。 Delivery device adapted to the use of a discontinuous, i.e., the day the number of injections required amount of drug administered, or which is adapted by permanent fluid communication between the delivery device and the patient communicates continuously conveyed continuously or similar drugs. 前一种型式的设备经常称作笔设备,后一种型式的设备经常称作输液泵。 The former type of device is often referred to as a pen device, the latter type of device is often referred to as an infusion pump.

[0004]"笔"通常是机械笔形式的设备,然而,其可具有任何所需的结构,正像其可包括用于辅助药物注射的马达。 [0004] "pen" is typically in the form of a mechanical pen device, however, it may have any desired configuration, just as it may comprise a motor for assisted injection of drug.

[0005] 基本上,输液泵可分成两类。 [0005] Basically, infusion pumps can be divided into two categories. 第一类包括耐久输液泵,该输液泵相对昂贵,预计能够使用3-4年,由于此原因,这种泵的最初成本经常是这种疗法的障碍。 The first class comprises durable infusion pump, the infusion pump is relatively expensive, is expected to be used 3--4 years, for this reason, the initial cost of such a pump often is a barrier of this therapy. 尽管比传统的注射器和笔更加复杂,但是泵具有如下优点:连续注射胰岛素、剂量精确以及随意的可编程的分配轮廓、用户可启动的与膳食相关的快速注射。 Although more complex than traditional syringes and pens, the pump has the following advantages: continuous infusion of insulin, precision in dosing and programmable random distribution profile, the user may initiate the bolus associated with diet. 这种型式的泵的示例在美国专利US4562751 和US4685903中示出,所述专利结合在本申请中,作为参考。 Examples of such type of pump is shown in U.S. Patent No. US4562751 and US4685903, incorporated in the present patent application by reference.

[0006] 为解决上述问题,已经做出若干种尝试来提供成本低且便于使用的第二类药物注射设备。 [0006] To solve the above problem, several attempts have been made to provide a low cost and convenient to use a second drug injection device. 一些这些设备是部分或全部一次性的,并具有与输液泵相关连的优点,而没有附加成本和不便,例如,泵可被预先装满,因此就不需装满或重装满储存室。 Some of these devices are partially or fully disposable, and has the advantages associated with an infusion pump connected, without an additional cost and inconvenience, e.g., the pump may be prefilled, and therefore does not need re-filled or filled storage chamber. 这种型式的注射设备的例子可从以下美国专利中获知:US4340048和US4552561 (基于渗透泵)、 US5858001 (基于活塞泵)、US6280148 (基于隔膜泵)、US5957895 (基于流量限制泵(也称作渗漏孔泵))、US5527288 (基于气体发生泵)、或者US5814020 (基于膨胀凝胶),这些都是最近十年提出的,以用于不昂贵的、初级一次性药物注射设备,所引用的文献结合在本申请中作为参考。 Examples of this type of injection device is known from the following U.S. Patents: US4340048 and US4552561 (based on osmotic pumps), US5858001 (based on a piston pump), US6280148 (based diaphragm), US5957895 (based on the pump flow restriction (also called retentate leak pump)), US5527288 (based on a gas generating pump), or US5814020 (based on the swollen gel), which are proposed recently years, for an inexpensive, disposable drug primary injection device, the references cited incorporated by reference in the present application.

[0007] —次性泵通常包括接触皮肤的安装面,该安装面适于通过粘结手段应用于注射对象的皮肤上,并且带有输注针,其设置为使得在使用状态下,其从安装面突出,以由此穿透注射对象的皮肤,由此针穿透皮肤的位置在设备使用的同时被盖住。 [0007] - views of the pump generally comprises a skin-contacting mounting surface, the mounting surface is adapted to be applied to the injection target skin by bonding means, and with the infusion needle arranged such that, in use, from which projecting mounting surface to thereby penetrate the skin of the injection target, whereby the position of the needle penetrates the skin is covered while the device is in use.

[0008] 在流体药物被提供给用户时,重要的是,用户可以在视觉上检查药物,以确保药物例如没有因自缔合或者渗透而结晶或者聚合,或者确保药物已经发生任何其他的视觉上可检测的变化,如活性药物的氧化。 [0008] When the fluid medicament is provided to the user, it is important that the user can check visually the drug to ensure that the drug, for example, is not due to self-association or penetration crystallized or aggregated, or ensure that the drug has occurred on any other visual detectable change, such as oxidation of the active drug. 对于胰岛素来说,这种视觉变化通常称作"原纤维化"。 For insulin, this visual change often called "fibrillation." 甚至较弱程度的原纤维化对病人来说也很关键,这是由于其潜在地造成胰岛素的过敏性,并改变胰岛素的时间表。 Even the weaker degree of fibrillation is also critical for the patient, because of its potential to cause allergic insulin, insulin and change the schedule. 然而,实际上,检查到弱的原纤维化相对困难,即使在良好照明条件下的盒体内也是如此。 However, in practice, to check the weak fibrillation relatively difficult, even within the cartridge under good lighting conditions as well.

[0009] 鉴于上述的现有设备,本发明的目的是提供一种药物输送设备,该药物输送设备包括或者适于包括具有有助于用户检查药物状态的手段的包装量的液体药物,例如,用于检查原纤维化的胰岛素。 [0009] In view of the above-described conventional apparatus, an object of the present invention is to provide a drug delivery device, the drug delivery device comprising or adapted to comprise a liquid amount of a pharmaceutical pack means helps the user to check the status of the drug, e.g., for checking proinsulin fibrosis. 本发明的另一个目的是提供一种设备,其允许以有效方式检查药物的状态。 Another object of the present invention is to provide an apparatus which allows to check the state of the drug in an efficient manner.

发明内容 SUMMARY

[0010] 在本发明的实施例的披露内容中,将叙述本发明的实施例和几个方面,其实现了 [0010] In an embodiment of the present disclosure of the invention, the embodiment of the present invention will be described embodiments and aspects, which achieves

一个或多个上述目的,或者其将实现从以下披露内容以及从示范性实施例的叙述中明显看出的目的。 One or more of the above objects or which will achieve apparent from the following description and examples from the disclosure in an exemplary purposes.

[0011] 因此,在第一个方面,提供一种药物输送设备,其包括适于容纳液体药物的储存 [0011] Thus, in a first aspect, there is provided a drug delivery device comprising a medicament reservoir adapted to receive a liquid

室、排出组件,该排出组件在使用状态下将药物从储存室排出。 Chamber, an exhaust assembly, the exhaust assembly in the use state is discharged from the medicament storage compartment. 该设备还包括具有光线入口和光线出口的光导管和透明区域,该光导管适于从进入点引导光线并使其进入储存室,该透明区域允许用户或者外部设备来检查储存室的一部分,以由此检测光通过药物的传输特征。 The apparatus further comprises a light inlet and a light outlet of the light guide and the transparent region, the light guide is adapted to guide the light from the entry point and into the storage chamber, the transparent region allows the user to examine a portion or the external device of the storage chamber to thereby detecting the transmission characteristics of light through the drug. 如果使用外部检测设备,则光线不必是人眼可以看到的。 If an external detection device, the light need not be visible to the human eye. 以这种方式,外部光源可用于有效照亮储存室,以用于检查,正像光导管可用于从方便的进入点将外部光线引导到储存 In this manner, an external light source can be used to effectively illuminate the storage chamber, for inspection, just as the light pipe can be used to easily access point from external light guided to the reservoir

室。 room. 然而,光导管也可用于发送设备内产生的光线,例如,从设置在便利位置处的LED产生的光线。 However, the light pipe can also be used to produce light in the transmission device, e.g., the light from the LED is provided at a convenient location generated. 光导管可以是直的,或者适于以非直线方式引导光线,例如,其可以是柔性的,或者其包括在光导管内改变光线方向或者使光线偏转的小平面。 Light pipe can be straight or non-linear manner adapted to guide the light, for example, which may be flexible, or it comprises changing the direction of light within the plane of the small light pipe or beam deflection. 在本发明的上下文中,术语光导管也涵盖了术语光引导管和光管。 In the present context, the term also covers the terms light guide guiding the light pipe and a light pipe.

[0012] 透明区域可单独地由储存室本身形成,例如,用户将直接观察储存室的透明部分, 或者储存室的透明部分可由更透明的部件覆盖,例如,设置在壳体上的窗户,储存室设置在该壳体内。 [0012] The transparent region may be formed separately from the storage chamber itself, for example, a user to directly observe the transparent portion of the storage chamber, the storage chamber or the transparent portion may be made more transparent cover member, e.g., a window disposed on the housing, storage chamber disposed within the housing. 尽管一个(或多个)透明区域从字面上讲将引导光线,但是,只是用作透明障碍的这种结构在本发明的上下文中不认为是"光导管"。 Although one (or more) regions from a transparent light guide literally, but only as a transparent barrier in the context of the present invention, such a configuration is not considered "light pipe." 在优选实施例中,光导管设置在可视路径的外部,用户可通过该可视路径来检查储存室。 Embodiment, the light pipe disposed outside, the user can be checked by visual path in the storage chamber is visible path in the preferred embodiment.

[0013] 传输特征可以是任何适当的传输特征:(i)受到药物的相关非恒定特征的影响(例如,原纤维化),并可由用户或者该设备外部的检测装置检测。 [0013] The transmission characteristic may be any suitable transmission characteristics: (i) non-affected by relevant pharmaceutical characteristics constant (e.g., fibrillation), and may be detected by the user or detection means external to the apparatus. 例如,聚焦的光线或漫射光将被分散在原纤维化的胰岛素中,用户或者其他检测装置将从视觉上确认分散(以给定水平)。 For example, light focused or diffuse light would be dispersed in fibrillated insulin, the user or other detection means to confirm the dispersion (at a given level) will visually.

[0014] 光线入口可设置成用来接收从设备外部产生的光线,或者该设备可包括与光线入口相连的光源。 [0014] The light inlet may be arranged to receive light generated from an external device, or the device may include a light source connected to the inlet. 因此,使用的光线可主要是不同的两种,由人眼可检测的光线或者不可由人眼检测的光线,这两种可以组合使用。 Thus, the light may be mainly used two different light detectable by the human eye or not can be detected by the human eye light, the two can be combined. 在设备适于由用户视觉检测的情况下,可见光与透明区域结合使用,允许用户检查一部分设备,其中,光束被引导通过该设备。 In the case where the device is adapted to detect the user's vision, the visible light transparent region in combination with the use, allowing the user to check the part of the device, wherein the light beam is directed through the apparatus. 在设备适于与对发射光敏感的外部检测装置(例如,光传感器) 一起使用的情况下,光线可以是人眼可见到或者不可见到的。 In the case of apparatus suitable for use with the light emission is sensitive to external detecting means (e.g., optical sensor), the light may be visible to the human eye or not seen. 实际上,同一可见光束可以用于两种目的。 In fact, the same beam of visible light can be used for two purposes.

[0015] 将一个或多个光导管设置为基本照亮储存室的内部,或一个或多个光导管适于引导一束或多束光线通过储存室。 [0015] The interior of the one or more light pipes disposed substantially illuminate the storage chamber, or one or more light pipe adapted to guide one or more beams of light through the storage chamber.

[0016] 在转向上述披露的实施例中的储存室和泵装置的示例之前,将叙述本发明的不同方面。 [0016] Before exemplary storage chamber and the pump in the embodiment of the steering apparatus disclosed in the above, it will be described various aspects of the invention. [0017] 因此,在另一个方面,提供一种药物输送设备,其包括适于容纳液体药物的储存室和排出装置,该排出装置在使用状态下将药物从储存室排出。 [0017] Thus, in another aspect, there is provided a drug delivery device, which comprises a storage chamber adapted to receive a liquid medicament and a discharge device, the discharge device is discharged from the medicament storage compartment in the use state. 该设备还包括照明装置和检测装置,其中,照明装置用于引导光线通过药物,检测装置允许光线穿过药物的传输特征被检测。 The apparatus further comprises an illumination means and the detection means, wherein the illuminating means for directing light through the drug, allowing light to pass through the detecting means is detected transmission characteristic of the drug.

[0018] 传输特征可以是任何适当的传输特征:(i)受到药物的相关非恒定特征的影响(例如,原纤维化),并可由用户或者结合到该设备上的检测装置检测。 [0018] The transmission characteristic may be any suitable transmission characteristics: (i) non-affected by relevant pharmaceutical characteristics constant (e.g., fibrillation), and detecting means for detecting the on or incorporated into the device by the user. 例如,聚焦的光线或漫射光将被分散在原纤维化的胰岛素中,用户或者其他检测装置将从视觉上确认分散(以给定水平)。 For example, light focused or diffuse light would be dispersed in fibrillated insulin, the user or other detection means to confirm the dispersion (at a given level) will visually.

[0019] 在示范性的实施例中,照明装置包括具有光线入口和光线出口的光导管,光导管 [0019] In an exemplary embodiment, the lighting device comprises a light pipe, the light pipe light inlet and light outlet

适于从进入点引导光线并使其进入储存室,其中,检测装置包括透明区域,该透明区域允许 Adapted to direct light from the entry point and into the storage chamber, wherein the detecting means comprises a transparent area, the transparent area allows

用户检查一部分储存室。 User checks a portion of the storage chamber. 以这种方式,外部光源可用于有效地将储存室照亮,以用于检查, In this manner, external light sources may be used to effectively illuminate the storage chamber, for inspection,

正如光导管可用于从入口的便利点引导外部光线到储存室。 As the light pipe to be used to direct external light from a convenient point storage chamber inlet. 然而,光导管也可用于发送设 However, the light pipe may be provided for transmitting

备内所产生的光,例如,从设在便利位置处的LED所产生的光。 The light generated within the apparatus, for example, provided at a convenient location from the light generated by the LED. 光导管可以是直的,或者适 Light pipe may be straight, or appropriate

于以非直线方式引导光线,例如,其可以是柔性的,或者其包括在光导管内改变光线方向的 To direct the light in a non-linear manner, for example, which may be flexible, or that includes a light-redirecting light pipe in the

小平面。 Small plane. 在本发明的上下文中,术语光导管也涵盖了术语光引导管和光管。 In the present context, the term also covers the terms light guide guiding the light pipe and a light pipe.

[0020] —个或多个光导管可设置成基本将储存室的内部照亮,或者一个或多个光导管可 [0020] - one or plurality of light pipes may be arranged to substantially illuminate the interior of the storage chamber, or may be a plurality of light pipes or

适于引导一束或多束光线通过储存室。 Adapted to direct one or more beams of light through the storage chamber.

[0021] 储存室可包括第一和第二柔性箔片部件,该第一和第二柔性箔片部件密封到一起,从而形成袋形结构的储存室,袋形结构限定了总平面,该储存室具有圆形边缘部分。 [0021] The storage chamber may comprise a first and second flexible foil member, the first and second flexible foil members sealed together to form a bag-like structure storage chamber, the bag-like structure defining a general plane, the reservoir chamber has a rounded edge portion. 对于这种储存室来说,光线被引导穿过圆形边缘部分,该圆形边缘部分将具有大致与总平面垂直设置的部分。 For such a storage chamber, the light is guided through the circular edge portion, the edge portion of the circular portion having a general plane substantially perpendicular disposed.

[0022] 在另一个示范性实施例中,照明装置包括发光装置和检测装置,该发光装置适于引导光束穿过药物,检测装置允许光束穿过药物的传输特征被检测。 [0022] In another exemplary embodiment, the lighting device comprising a light emitting means and the detection means, the light emitting means adapted to direct a light beam through the drug, allowing the light beam detecting means through the transmission characteristics of the drugs is detected.

[0023] 光束可被引导穿过一部分储存室,或者在设备包括设在储存室和出口之间的通道的情况下,光束被引导穿过一部分通道。 [0023] The beam can be directed through a portion of the storage chamber, or, in the case where the apparatus comprises a storage chamber disposed between the passage and an outlet, the beam is directed through a portion of the passage. 这种通道可以是储存室和泵之间的运输管道,或者其可以是一部分排出装置,例如,形成为泵的一部分的管道或者空间。 Such a channel may be a transport conduit between the pump chamber and the reservoir, or it may be a part of the discharge means, e.g., a space portion is formed as a pipe or a pump. 通道可包括与检测装置相连的腔体,并适用于检测目的。 Channel may comprise a cavity connected to the detecting means and suitable for detection purposes. 使用适用于检测目的的腔体或通道的另一部分也允许药物在完全或部分从视线隐藏时(例如,在封闭于泵内时)被检测,或者其可允许相关药物特征的更准确测定,就如同利用储存室能够进行检测一样。 Another portion using suitable detection purposes cavities or channels also allow the drug accurate determination of completely or partially from the line of sight hidden (e.g., when enclosed within the pump) is detected, or it may allow the drugs features more in it as can be detected using the same storage chamber.

[0024] 使用的光线主要有两种不同的种类,S卩,可由人眼检测到的光线或者不可由人眼检测到的光线,这两种光线可组合使用。 [0024] There are two main light use different types, S Jie, detected by the human eye to light or not light is detected by the human eye, the two light can be used in combination. 在设备适于由用户视觉检测的情况下,可见光用于与透明区域形式的检测装置结合,该检测装置允许用户检查一部分设备,其中,光束被引导通过该设备。 In the case where the device is adapted to detect the user's vision, used in conjunction with visible light transparent region in the form of detecting means, detecting means which allows the user to check the part of the device, wherein the light beam is directed through the apparatus. 对于这种应用,该设备有利地设有开关,以允许用户在需要时打开光束。 For this application, the apparatus is advantageously provided with a switch to allow the user to open the beam when desired. 在设备设有对发射光敏感的检测装置(例如,光传感器)的情况下,光线可以是人眼可见到或者不可见到的。 In the case where the device is provided with detection sensitive to light emitting means (e.g., optical sensor), the light may be visible to the human eye or not seen. 实际上,同一束可见光束可以用于两种目的。 In fact, with a bunch of visible light it can be used for two purposes.

[0025] 在示范性的实施例中,检测装置包括控制装置、光检测装置,其中,光检测装置适于检测从发光装置发出的光线,并将表示检测光线特征的信号传输到控制装置,该控制装置适于确认表示给定药物的第一状态的第一信号范围、确认指示药物的第二状态的第二信号范围以及在确认第二状态时产生信号。 [0025] In an exemplary embodiment, the detection means comprises a control means, light detecting means, wherein the light detecting means adapted to detect light emitted from the light emitting device, and transmits a signal detected light to the control means characterized in that a first control means is adapted to confirm the range signal indicates a first state of a given drug, confirming the second state signal indicating a second range of drugs and generating a second signal when the acknowledgment state. 例如,第一范围与没有原纤维的或者只有最低程度原纤维的胰岛素相关,第二范围与在上述预定水平之上的原纤维的胰岛素相关。 For example, the first range is not associated with fibrils or fibril only minimal insulin, proinsulin associated with a second range of fibers on the predetermined level. [0026] 该设备也包括多个光线检测装置,各个光线检测装置适于检测从发光装置发出的光,并将指示检测光线特征的信号传输给控制装置,其中,控制装置基于传输的信号来确认给定药物的第一和第二状态,并且在确认是第二状态时产生信号。 [0026] The apparatus also includes a plurality of light detecting means, each light detecting means adapted to detect light emitted from the light emitting means and the light detection signal indicative of transmission characteristics to the control device, wherein the control means based on a signal transmitted acknowledgment to the first and second states of a given drug, and the confirmation signal is generated when the second state. 通过依靠一个以上的传感器,可以提供更稳固和/或敏感的检测。 By relying on one or more sensors, it may provide more stable and / or sensitive detection.

[0027] 发光装置可以与储存室或通道一体形成,或者其可设置在结构外部,其中,药物封闭在该结构内,该结构包括允许光束进入结构的透明部分。 [0027] The light emitting device may be formed integrally with the storage chamber or passage, or it may be provided outside the structure, wherein the drug enclosed within the structure, the structure comprising a transparent portion allowing the light beam to enter the structure.

[0028] 不管实际的检查或检测设置,储存室可包括第一和第二柔性箔片部件,该第一和第二柔性箔片部件密封到一起,从而形成袋形结构的储存室,袋形结构限定了总平面,该储存室具有圆形边缘部分。 [0028] Regardless of the actual inspection or detection setting storage chamber may comprise a first and second flexible foil member, the first and second flexible foil members sealed together to form a bag-like structure storage chamber, the bag-shaped structure defining a general plane, the reservoir chamber having a rounded edge portion. 对于这种储存室来说,光线被引导穿过圆形边缘部分,该圆形边缘部分将具有大致与总平面垂直设置的部分。 For such a storage chamber, the light is guided through the circular edge portion, the edge portion of the circular portion having a general plane substantially perpendicular disposed.

[0029] 在提供了由箔片材料提供的柔性储存室时,排出装置可以是抽吸泵形式,该抽吸泵在使用状态下泵入口和储存室流体连通。 [0029] In providing a storage chamber provided by a flexible foil material, the discharge means may be in the form of a suction pump, the pump suction inlet and a fluid storage chamber in communication with the state of use.

[0030] 储存室也可以是活塞可滑动地设置在其内的圆柱形部件的形式,S卩,与通常用于笔注射设备和输液泵的盒体类相应。 [0030] The storage chamber may be a cylindrical member in the form of a piston slidably disposed therein, S Jie, the box supporting the pen injection device and commonly used for the respective infusion pump. 这种储存室可以是用户注满的或者预先注满的,正如其可插入到药物输送设备中或者可与之一体形成。 Such storage chamber may be filled or user filled in advance, as it can be inserted into the drug delivery device, or may be formed integrally therewith. 这种设备通常将包括活塞致动器、用于控制活塞致动器的电子控制器和例如与通常的耐用输液泵相应的能源。 Such apparatus typically comprises a piston actuator, an electronic controller for controlling the piston actuator, for example, and a conventional durable infusion pump with appropriate energy.

[0031] 不管储存室的型式和排出装置的型式,在示范性的实施例中,本发明的药物输送设备可包括适于向注射对象的皮肤应用的下表面和适于穿透注射对象的皮肤的经皮设备。 [0031] Regardless of the type pattern of the storage chamber and the discharge apparatus, in the exemplary embodiment, the drug delivery device of the present invention may be adapted to adapted to penetrate the injection target include the lower surface of the skin and application of the subject's skin injection the transcutaneous device. 输送设备的出口可适于与输注组件(与通常的输液泵相应)配合,或者该设备可设有经皮接入装置,即针、软套管、微型针阵列或者非侵入性经皮装置,其在使用状态下从设备的下表面突出或者设置在其上,这种设备包括粘性的下表面。 Outlet conveyor apparatus may be adapted to infusion (corresponding to the infusion pump typically) complex, or the apparatus may be provided with a percutaneous access device, i.e. a needle, a soft cannula, a micro needle array, or a non-invasive transdermal devices , which protrudes in the use state from the lower surface of the device, or arranged thereon, which apparatus includes a lower surface tack.

[0032] 然而,本发明的原理也可用于"笔"型式的输送设备,这种设备包括可移动到选择的设置位置的剂量设定部件以及允许设置的剂量排出的用户致动部件,其中,该选择性设置位置表示待输送的药物的设定剂量。 [0032] However, the principles of the present invention can also be used in "pen" type conveying apparatus which includes a movable member provided to the position of the dose setting the user selected and arranged to allow discharge of the dose actuating member, wherein, this selective setting position indicates the set dose of medication to be delivered. 该排出装置可完全是机械的,或者马达可用来驱动排出装置。 The discharge device may be entirely mechanical, or a motor used to drive the discharge means.

[0033] 术语出口用来指示这样一种结构,即,其将在药物从输送设备的实际输送过程中用作出口。 [0033] The term outlet is used to indicate such a configuration, i.e., which will serve as an outlet during actual delivery in the drug delivery device. 换句话说,在实际上不使用时,可将出口关闭。 In other words, when not actually in use, the outlet closed. 例如,出口可以是针可剌穿的隔膜形式,其将被关闭,直至将针设置为从其穿过。 For example, the outlet may be a needle pierces the membrane form, which will be closed until the needle to pass therethrough. 出口也可设有阀,该阀将关闭出口,直至输送排出装置被启动。 May also be provided with an outlet valve, the outlet valve closes until the discharge conveying means is activated.

[0034] 如此处所用的,术语"药物"意味着包括任何含有药物的可流动药品,该药品能够以可控方式流动通过分配装置如中空针,该药品如液体、溶液、凝胶或者微悬浮液。 [0034] As used herein, the term "drug" is meant to encompass any drug-containing flowable medicine, the drug in a controlled manner a flow through the dispensing means such as a hollow needle, the drug such as a liquid, solution, gel or fine suspension liquid. 代表性的药物包括药剂如肽、蛋白质(例如,胰岛素、胰岛素类似物和C肽),以及激素、生物衍生剂或者活性剂、基于激素和基因的试剂、营养配方和其他固体(分配的)或者液体形式的物质。 Representative drugs include agents such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other solid (dispensed) or the liquid form of the material. 在示范性实施例的叙述中,将参考使用胰岛素的情况进行叙述。 In the exemplary embodiment described in the embodiment, with reference to the use of insulin will be described. 相应地,术语"皮下"输注是指包括经皮输送到注射对象的任何方法。 Accordingly, the term "subcutaneous" infusion is meant to include any method of percutaneous delivery to the injection subject. 此外,术语针(在没有其他说明时)限定为适于穿透注射对象皮肤的剌穿部件。 Further, the term needle (when not otherwise specified) is defined through the injection member is adapted to penetrate the subject's skin puncture. 附图说明 BRIEF DESCRIPTION

[0035] 在下文,将参考附图叙述本发明。 [0035] Hereinafter, the present invention will be described with reference to the accompanying drawings. 其中 among them

[0036] 图1是示出模块化药物输送设备的一个实施例的透视图, [0036] FIG. 1 is a perspective view showing one embodiment of a modular drug delivery device,

[0037] 图2是示出储存单元的分解视图, [0037] FIG. 2 is an exploded view illustrating the storage unit,

[0038] 图3部分地示出包括光导管的储存单元, [0038] FIG. 3 shows a section storage unit comprises a light guide,

[0039] 图4部分地示出包括光导管的另一个储存单元, [0039] FIG. 4 shows another partially storage unit comprises a light guide,

[0040] 图5示出输送设备的示意图, [0040] FIG. 5 shows a schematic view of the delivery device,

[0041] 图6示出笔型式的输送设备, [0041] FIG. 6 shows a pen type delivery device,

[0042] 图7示出另一个输送设备的示意图, [0042] FIG. 7 shows a schematic view of another delivery device,

[0043] 图8A-8E示出包括光源的储存单元的示意性实施例,以及 [0043] FIGS. 8A-8E illustrates the storage unit comprising a light source exemplary embodiment, and

[0044] 图9示出本发明一个方面的实验结果。 [0044] FIG 9 shows the experimental results of the present invention to an aspect.

[0045] 在附图中,相同的结构用相同的附图标记表示。 [0045] In the drawings, the same structure represented by the same reference numerals.

具体实施方式 Detailed ways

[0046] 在下文中,在采用术语如"上"和"下"、"右"和"左"、"水平"和"垂直"或者类似相对表达时,这些术语只是参考附图而不是其实际使用位置。 [0046] Hereinafter, when using the terms such as and "lower", "upper", "right" and "left", "horizontal" and "vertical" or the relative expression of the like, these terms only with reference to the accompanying drawings instead of actual use position. 示出的附图是示意性表示,为此,不同结构的配置以及其相对尺寸只是起到说明性目的。 Shown in the drawings is a schematic representation, for this, the configuration and relative dimensions of its different structures play only illustrative purposes.

[0047] 首先,参考图l,将叙述模块化药物输送设备的一个实施例。 [0047] First, referring to FIG. L, will be described an embodiment of a modular drug delivery device. 输送设备作为一个型 As a type of delivery device

式的设备的示例而示出,其中,在该型式的设备中,可以有利地实施本发明,然而,本发明可 Formula exemplary apparatus is shown, wherein, in the type of apparatus, the present invention can be advantageously implemented, however, the present invention can be

与在其中需要检查药物特征的任何药物输送设备结合使用。 And in which the need to check the features of any pharmaceutical drug delivery device used in combination.

[0048] 经皮设备单元2包括针形式的经皮设备,因此在下文中称作针单元。 [0048] The transcutaneous device unit 2 comprises a transcutaneous device in the form of a needle, the needle unit so referred to hereinafter.

[0049] 更具体地说,图1示出形式为模块化的可安装在皮肤上的药物输送设备1的医疗 [0049] More specifically, Figure 1 shows a modular form of a skin mountable drug delivery medical device 1

卫生器材的透视图,该药物输送设备1包括片形的针单元2和储存单元5。 A perspective view of the medical devices, the medicament delivery device 1 comprises a sheet-like needle unit 2 and the storage unit 5. 在供给用户时, When supplied to the user,

各个单元优选被包围在其自身的密封包装(未示出)中。 Each unit is preferably enclosed in its own sealed package (not shown).

[0050] 针单元包括基部10和壳体部20,其中,基部10具有适用于应用到用户皮肤上的下安装面,壳体部20中设有中空输注针(未示出)。 [0050] The needle unit comprises a base portion 10 and a housing 20, which has a base 10 suitable for application to the mounting surface of the user's skin, the housing portion 20 is provided with a hollow infusion needle (not shown). 针包括适于剌穿用户的皮肤的远侧部以及适于设置成与储存单元流体连通的近侧部。 Adapted to the user including a needle pierces the skin of a proximal portion and a distal portion in fluid communication with the storage unit is adapted to be disposed. 针的远侧部可在初始位置和延伸位置之间移动,其中,远端在初始位置相对于安装面收縮,在延伸位置相对于安装面突出。 The needle distal portion is movable between an initial position and an extended position, wherein the distal end with respect to the attachment surface in the contracted initial position, in the extended position relative to the mounting surface of the projection. 此外,针可在延伸位置和收縮位置之间移动,其中,远端在延伸位置相对于安装面突出,在收縮位置相对于安装面收縮。 Further, the needle is movable between an extended position and a retracted position wherein the distal end in the extended position projecting relative to the mounting surface, the mounting surface with respect to the shrinkage in the retracted position. 针单元还包括用户可握住的致动装置,其形式为带形部件21、22,以分别致动收縮的针。 Needle unit further comprises actuating means can hold the user in the form of a belt-shaped member 21, respectively actuated retractable needle. 壳体还包括用户可致动的凸形连接装置40 ,该凸形连接装置40形式为一对弹性设置的钩形部件,适于与储存单元上的相应的凹形连接装置配合,这就允许储存单元在使用状态可释放地固定到针单元上。 The housing further comprising a user-actuatable male coupling means 40, the male coupling means 40 in the form of a pair of hook members provided an elastic, means adapted to cooperate with a corresponding female connector on the storage unit, which allows in the use state storage unit may be releasably secured to the needle unit. 基部包括连接到更加柔性的粘结板部件12上的相对刚性的上部11,该粘结板部件12具有自身设置安装面的下粘结表面,粘结表面可设有可剥离的保护板。 Comprising a base portion connected to a more flexible adhesive sheet member on a relatively rigid upper portion 1211, the bonding plate member 12 having a lower adhesive surface itself is provided a mounting surface, an adhesive surface may be provided with a peelable protective sheet. 基部也包括脊部件13,其适于与储存单元上的相应凹槽接合。 Base member 13 also includes a ridge, corresponding recesses in the storage unit which is adapted to engage. [0051] 储存单元5包括预先装满的储存室和排出装置,其中,储存室含有液体药物配方(如,胰岛素),排出装置形式为可电子控制的泵,以在使用状态通过针将药物从储存室排出。 [0051] The storage unit 5 includes a pre-filled reservoir chamber and the discharge apparatus, wherein the storage chamber containing a liquid drug formulation (e.g., insulin), the pump means may be discharged in the form of electronic control, to the use of the drug through the needle from the state storage chamber is discharged. 储存单元具有通常为平的下表面,该下表面适于安装到基部的上表面上,并且该储存单元包括凸出部50以及凹形连接装置51,该凸出部50适于被接收在壳体部20的相应腔体内,凹形连接装置51适于与针单元上的相应钩部件31接合。 The storage unit has a generally flat lower surface, the lower surface adapted to be mounted on the upper surface of the base, and the storage unit includes a projecting portion 50 and the female connection means 51, the projecting portion 50 adapted to be received in the housing a respective cavity 20 of the body portion, the female coupling means 51 engages with a corresponding hook member on the needle unit 31 is adapted. 凸出部提供了两个单元之间的界面,并包括泵出口和接触装置(未示出),以允许在两单元被装配时可以启动泵。 The projecting portion provides the interface between the two units and comprises a pump outlet and contact means (not shown), to allow the pump may be started when the two units are assembled. 下表面也包括窗口(不可看到),以允许用户可视觉上控制储存室的容量,然而,这种窗口也可设置在储存单元的上自由表面上。 The lower surface also comprises a window (not visible), to allow the user to visually control the capacity of the storage chamber, However, such a window may be provided on the free surface of the upper storage unit.

[0052] 参考图2,示出适于与上述针单元一起使用的一种型式的储存单元450的实施例, 或者其包括一个整体式设备的储存室/泵部,储存单元包括壳体451,柔性的箔片储存室460、泵单元470以及控制和致动装置设置在该壳体451内,其中,泵单元470形式为可机械致动的隔膜泵。 [0052] Referring to Figure 2, shows an embodiment of a type suitable for use with the needle unit, a storage unit 450, or a monolithic device comprising a storage chamber / pump unit, a storage unit 451 including a housing, a flexible foil storage chamber 460, the pump unit 470 and the control and actuating means disposed within the housing 451, wherein the pump unit 470 in the form of a mechanically actuated diaphragm pump. 壳体包括显示窗口452,该显示窗口452可用于为用户提供信息,例如,储存室内剩余的药物量,或者有关故障状态的信息,和/或允许用户视觉上检查储存室的容量。 Housing 452 comprises a display window, the display window 452 may be used to provide information to the user, e.g., storing information of the remaining amount of the drug chamber, or the relevant fault condition, and / or allow the user to visually check the capacity of the storage chamber. 控制和致动装置包括泵致动部件、微处理器483、信号产生装置485和能源486,其中,该泵致动部件的形式为杠杆和活塞装置481,并由线圈致动器482驱动,该微处理器483用于控制储存单元的不同功能,该信号产生装置485用于产生可听到和/或触到的信号。 Control and actuation means comprises a pump actuating member, a microprocessor 483, a signal generating means 485 and 486 of energy, wherein the pump actuation member in the form of a lever and piston arrangement 481 driven by a coil actuator 482, the the microprocessor 483 for controlling the different functions of the storage unit, signal generating means 485 which produces an audible signal and / or for touch. 不同的部件设置在印刷电路板(PCB)480上。 Various components disposed on the printed circuit board (PCB) 480. 在示出的实施例中,储存室设置在PCB之上,然而,可替换地,其可与检查窗口结合,设置在PCB之下,其中,检查窗口设置在储存单元的下表面上。 In the illustrated embodiment, the storage chamber disposed above the PCB, however, alternatively, it may be combined with the inspection window disposed under the PCB, wherein the inspection window provided on the lower surface of the storage unit. [0053] 本发明的不同实施例可具体表现为储存单元450。 [0053] The various embodiments of the present invention may be embodied as a storage unit 450. 例如,光源(未示出)可设置在PCB上,光源引导彩色光束穿过经窗口452可视的储存室的一部分。 For example, a light source (not shown) may be provided in the PCB, the color beam through a light guide window of a portion of the storage chamber 452 visible. 光束的宽度可选择为允许光束穿过未原纤维化的胰岛素,以使用户的眼睛不可看到,即,光束如此窄,为实际应用目的,其将不被观测到。 The width of the beam may be selected to allow the light beam passes through non-fibrillated insulin, so that the user can not see the eye, i.e., such a narrow beam, for the purposes of practical application, it will not be observed. 以这种方式,非原纤维化的胰岛素将造成指示为"off"。 In this way, non-insulin will cause fibrillation is indicated as "off". 然而, 如果胰岛素原纤维化,则由于其与胰岛素中的原纤维相互作用,光线将变得分散,这种分散使光散射,从而使得用户能够看到,潜在地警告不再使用胰岛素。 However, if insulin fibrillation, due to the interaction with the insulin fibrils, the light will be dispersed, such a dispersion scatter light, so that the user can see, no warning potentially use insulin. 实际上,给定量的原纤维化将是必须的,以便产生可视的分散光,然而,已经发现(参见下文),在原纤维化变得可视之前,光分散可由未训练过的眼睛(untrained eye)看到。 Indeed, a given amount of fibrillation will be necessary to produce a dispersion of visible light, however, it has been found (see below), prior to fibrillation becomes visible, the light dispersed by the untrained eye (untrained eye) to see.

[0054] 根据光源的型式,其可设有透镜,以聚焦光线,从而产生光束。 [0054] The type of light source, which may be provided with lenses to focus the light to produce a light beam. 光线本身例如可由激光二极管或者正常的LED产生。 Light itself, for example, be generated by a laser diode or a normal LED. 如从上述的工作原理可明显看出,光线穿过储存室的壁部的传输不应该在其自身产生显著的分散量。 As apparent from the above principle, the light transmission through the wall portion of the storage chamber should not produce significant amount of dispersion on its own. 因而,对于柔性储存室来说,理想的是将专门的"光引导管"附装到储存室,从而适当地引导光线不分散地穿过箔片材料,或者光学硅酮(optical silicone)可用于在光源和储存室之间跨接间隙。 Accordingly, the flexible storage chamber, it is desirable to specifically "light guide tube" is attached to the storage chamber, so that the light is not dispersed appropriately guided through the foil material, a silicone or an optical (optical silicone) may be used bridging the gap between the light source and the storage chamber.

[0055] 图3示出去除了一部分壳体的储存单元650。 [0055] FIG. 3 illustrates part of the casing out of the storage unit 650 in addition. 储存单元包括泵单元670、柔性箔片储存室660和两个光导管690。 The storage unit includes a pump unit 670, a flexible foil reservoir chamber 660 and the two light guide 690. 储存室包括第一和第二柔性箔片部件,该第一和第二柔性箔片部件在三个边缘处密封到一起,从而形成袋形结构的储存室,袋形结构限定了总平面,该储存室具有圆形边缘部分(参见图4)。 Storage chamber comprising a first member and a second flexible foil, the first and second flexible foil members sealed together at three edges to form a bag-like structure storage chamber, the bag-like structure defining a general plane, the storage chamber has a rounded edge portion (see FIG. 4). 储存单元的下表面在使用状态下适于面朝皮肤表面,并设有透明区域680,以允许用户检查一部分储存室,以由此检查光线穿过药物的传输特征。 The lower surface of the storage unit is adapted in use state of the skin facing surface, and a transparent region 680 to allow the user to check a portion of the storage chamber, to thereby check the light passing through the transfer profile of the drug. 与图2的实施例相应,泵单元还包括带有附加部件的PCB(未示出)。 Embodiment 2 FIG respective pump unit further comprises a PCB having an additional member (not shown). [0056] 各个光导管包括带有光线入口端的直的入口部、和带有光线出口端的直的出口部,这两部分设置为相互成角度。 [0056] The light pipe comprises a respective straight inlet portion with a light inlet end, and a straight outlet portion with a light outlet end, the two portions disposed at an angle to each other. 入口端可形成储存单元的一部分外表面,正如光导管可与其他元件(例如壳体部) 一体形成。 The inlet end portion of the outer surface may form a storage unit, as the light guide may be integrally formed with other elements (e.g., housing portion). 在这两部分之间以及在出口端,设有小平面,以在该两部分之间引导光线,并且将该光线穿过出口端引导出去,使之沿着大致与储存室的总平面相应的方向进入储存室。 Between the two portions and at the outlet end, is provided with facets, in order to guide the light between the two portions, and the light passing through the exit end of the guide out, so that substantially along the general plane of the respective storage chamber direction into the storage chamber. 光学硅酮可用于在光导管和储存室之间跨接间隙。 Optical silicone may be used between the light conduit and the reservoir chamber bridging the gap. 在使用状态下,用户将光线入口朝向光源,例如灯,由此光线被引导至储存室,允许用户通过壳体(未示出)上的窗口来检查容量,窗口设置在储存单元的一个表面上或者相应的设备上。 In use, the inlet toward the light source to the user, such as a lamp, whereby light is directed to the storage chamber, allowing the user through the housing (not shown) to check the capacity window, the window is provided on a surface of the storage unit or a corresponding device. 可形成光导管,以提供储存室的散射照明或者提供两束光线。 Light pipe may be formed to provide diffuse illumination of the storage chamber or to provide two beams.

[0057] 图4部分地示出储存单元750的可替换实施例,其中,储存室760带有圆形边缘部分761,置于PCB的顶部。 [0057] FIG. 4 shows a section of the storage unit 750 may be an alternative embodiment, wherein the storage chamber 760 with a rounded edge portion 761, is placed on top of the PCB. 两个光导管790设置用来将光线从储存单元的下表面引导至储存室。 Two light pipes 790 arranged to direct light from the lower surface of the storage unit to the storage chamber. 光导管的出口端设有小平面,以沿着大致与储存室的总平面相应的方向引导光线进入储存室。 The outlet end of the light pipe is provided with facets, to direct light substantially along a general plane of the storage chamber into the storage chamber corresponding direction.

[0058] 代替在药物位于储存室内时检测药物的原纤维化,可替换地,检测也可在储存室外部的不同位置进行。 [0058] Instead of detecting fibrillation when the drug is a drug storage chamber, alternatively, may be detected at different positions outside the storage chamber. 在药物从储存室朝向出口排出时,这种位置通常是在储存室的下游。 When the drug is discharged toward the outlet from the storage chamber, which is usually a position downstream of the storage chamber. 以这种方式,可设有专门的检测结构,其将不依赖于给定储存室的固有特性。 In this manner, the detection may be provided with a special structure which does not depend on the inherent properties of a given storage chamber. 例如,其可制得复杂化,以引导光束穿过一部分柔性储存室或者穿过刚性盒体的壁,如在传统的玻璃盒体中一样。 For example, it can be prepared complex, to direct a light beam through a portion of the flexible storage chamber or through the wall of the rigid container body, as in the traditional glass cartridge body. 此外,对于柔性储存室来说,储存室的形式将在其排空时发生改变。 Further, the flexible storage chamber, the storage chamber forms will change when it is emptied. 相反,设置在储存室下游的专门结构可适用于优化所需的药物特性的检测这一单独目的,例如,胰岛素中的原纤维化。 Instead, special structure is disposed downstream of the storage chamber is adapted to separate the object of optimizing the detection of drug properties desired, e.g., fibrillation of insulin.

[0059] 相应地,在本发明的示范性实施例中,通道设在储存室和出口之间,发光装置适于引导光束穿过腔体内的药物,且检测装置适于检测光束穿过腔体内药物的药物传输特征。 [0059] Accordingly, in an exemplary embodiment of the present invention, the channel is provided between the storage chamber and the outlet, means adapted to direct a light beam through the light emitting medicament cavity, and the detecting means adapted to detect a light beam passing through the cavity pharmaceutical drug delivery characteristics. 该腔体可具有任何适当的结构,例如,形成为透明小容器、沟槽或者管道。 The chamber may have any suitable configuration, e.g., cuvette is formed, trenches or pipe. [0060] 图5示出与图2所示的相同型式的输送设备500的一个实施例的示意图。 [0060] FIG. 5 shows a schematic of an embodiment 500 of the type shown in the same delivery device 2 of FIG. 输送设备包括柔性箔片储存室560和泵单元570,储存室560包括针可剌穿的隔膜561,该隔膜561焊接到储存室的外表面上,泵单元570包括隔膜泵(未示出)、带有透明小容器的通道572、用于产生光束的光源575和光传感器576、577,以及能源586和用于控制泵、光源和传感器的处理器583。 Delivery device comprising a flexible foil reservoir chamber 560 and the pump unit 570, diaphragm 561 comprises a storage chamber 560 through the puncture needle, the membrane 561 is welded to the outer surface of the storage chamber, the pump unit 570 includes a diaphragm pump (not shown), a light source and a light sensor 575 with the passage 572 of the cuvette, for generating a light beam 576, 577, and 586, and for controlling the pump energy, light source and sensor processor 583. 透明小容器具有入口572和出口573,该入口572与设置穿过针隔膜的针580流体连通,并因此与储存室也流体连通,该出口573与泵(未示出)流体连通,泵具有与经皮接入设备590 (例如针)流体连通的出口。 Cuvette having an inlet 572 and an outlet 573, the inlet 572 is provided with a needle through the needle 580 in fluid communication with the separator, and thus also in fluid communication with the reservoir chamber 573 and the pump outlet (not shown) in fluid communication with the pump having outlet percutaneous access device 590 (e.g., a needle) in fluid communication.

[0061] 如果设备适用于视觉检查,则透明小容器的上侧将是透明的,从而提供一窗口,用户可以通过该窗口来检查透明小容器的内部,并因此使得光束从其通过。 [0061] If the upper side of the equipment for visual inspection, the cuvette will be transparent to provide a window, the user can check the interior of the cuvette through the window, and thus such light beams to pass. 如果透明小容器内的药物不包括可使光分散的任何成分,则光束不可由人眼看到,例如,像从激光二极管发出的窄且良好限定的光束,这与光的颜色无关,例如,红色光。 If the drug in the cuvette can not include any component of the light scattered, the light beam can not be seen by the human eye, e.g., as narrow emitted from the laser diode beam and well defined, regardless of the color of the light, e.g., red Light. 在药物改变其给定特征(例如,胰岛素开始原纤维化)时,则光将变得分散,并将因此使人眼可以看到,参见下文示例。 Drug given change its characteristics (e.g., insulin fibrillation starts), then the light will be dispersed, and thus human eye can see, see Example below. 在只需用户检测的情况下,可以省去传感器。 In the case where only the user detection sensor may be omitted.

[0062] 在设有一个或多个光检测传感器时,将能够自动地检测药物的所需特性。 [0062] When provided with one or more photo-detecting sensor, it will be able to automatically detect the desired properties of the drug. 更具体地说,传感器将用来检测从发光装置发出的光,并将指示被检测光特征的信号传输给控制装置。 More specifically, the sensor for detecting the light emitted from the light emitting device, and a signal indicating the detection light transmitted to the control device features. 例如,在光束传输穿过药物时,传感器577可设置在透明小容器的侧部以检测散射光。 For example, when the light beam transmitted through the drug, the sensor 577 may be provided in a side portion of the cuvette to detect the scattered light. 例如在药物原纤维化一定程度时,光束将变得分散,且光将到达传感器,这就表示着一定量的原纤维化(或者药物的其他特征)。 For example, when a certain degree fibrillated medicament, the beam will be scattered and light will reach the sensor, which represents the amount of fibrillated (drugs or other features). 相应地,控制器适用于确认指示给定药物的第一状态的第一信号范围(例如,没有原纤维化或者低水平的原纤维化)、确认指示药物的第二状态的第二信号范围(例如,不希望的原纤维化水平)、以及在已经确认第二状态时产生信号。 Accordingly, the second signal range, the first controller is adapted to a first state indicative of acknowledgment signal range given drug (e.g., low or no fibrillation fibrillation), a second state indicating acknowledgment drugs ( For example, undesirable levels of fibrillation), and generating a second signal when the state has been confirmed. 该信号用于警告用户注意该状态和/或停止泵。 This signal is used to warn the user about the status and / or stopping the pump.

[0063] 在使用两个或多个光检测器时(例如,分别检测散射和传输光线),控制装置将基于来自传感器的传输信号来确认给定药物的第一和第二状态,并在已经确认为第二状态时产生信号。 [0063] When two or more light detectors (e.g., to detect the light scattering and transmission), the control means to confirm the state of the first and second given drug based on the transmission of signals from the sensors, and has generating a signal when the second state is confirmed. 实际上,控制装置可适用于检测多于两种状态。 Indeed, the control device may be adapted to detect more than two states.

[0064] 通过提供自动检测,将能够连续地检测泵送药物的状态,而不需用户介入。 [0064] by providing automatic detection, we will be able to detect the state of continuously pumping the drug, without user intervention. 这可与药物输送设备的正常操作模式相比,在该药物输送设备的正常操作模式中,通知用户检查在使用之前灌注的药物的状态。 This may be compared to the normal operating mode of the drug delivery device, in the normal operating mode of the medication delivery device informing the user to check a state before use of the drug infusion. 通过连续地检查药物的状态,在药物转移到设备之后或者在预先装满的设备投入使用之后,药物的变化是可能的。 By continuously checking the status of the drug, after the transfer of the drug to the device or after a pre-filled device in use, it is possible to change the drug. 例如,如果检测装置在泵之后设置,则将能够检测由通过泵的泵送而导致的药物变质。 For example, if the detection means is provided after the pump, then the deterioration of the drug can be detected by the pump caused by pumping. 实际上,自动检测和用户检测都可被设置,如图3中的实施例所示。 Indeed, the detection can be automatically detected and the user is provided, in the embodiment 3 shown in FIG.

[0065] 图6披露了适于结合到本发明的另一个药物输送设备100。 [0065] FIG 6 discloses another suitable for incorporation into a drug delivery device 100 of the present invention. 更具体地说,该设备是笔型式的注射设备,该设备适用于由用户设定药物剂量的不连续的皮下注射。 More specifically, the device is a pen type injection device, the device is suitable for discontinuous subcutaneous drug dose set by a user. 这种设备是手动地或者机动设置/启动的。 Such a device is manually or motorized provided / activated. 如图所示,设备具有箱形形状,这就使得该设备比更加传统形成的长而细的笔状更加适合使用。 As shown, the apparatus has a box shape, which makes long thin pencil forming the apparatus more suitable than the more traditional use. 输送设备150包括剂量设定部件171、致动部件175 和窗口180,该窗口180允许用户检查纵向设置的透明盒体。 Delivery device 150 comprises a dose setting member 171, actuating member 175 and the window 180, the window 180 allows the user to check the box body longitudinally disposed transparent. 根据本发明的一个方面,光源设置在输送设备内,从而产生穿过盒体的远端部的光束(参见图7)。 According to one aspect of the invention, a light source disposed within the delivery device, thereby generating a light beam passing through the distal end portion of the cartridge (see FIG. 7). 为了开启光源,设置了键172。 To turn on the light source, the key 172 is provided. 可替换地,光导管可用来引导光线穿过一部分储存室。 Alternatively, the light guide may be used to direct the light through a portion of the storage chamber. 在示出的实施例中,该设备还设有可拆卸的盖190。 In the embodiment illustrated, the apparatus 190 also has a removable cover.

[0066] 图7示意性示出图6所示的型式的输送设备200的半机动型式的内部。 [0066] FIG 7 schematically shows the internal semi-mobile version of the type shown in Figure 6 of the delivery device 200. 更具体地说,带有活塞202的盒体201装在未示出的壳体内。 More specifically, with the cartridge piston 202 is mounted within housing 201 is not shown. 在使用状态下,针将连接到盒体的远端。 In use, the distal end of the needle connected to the cartridge body. 活塞由活塞杆203移动,并形成第一剂量设定元件,该活塞杆203示出为螺纹杆。 The piston 203 is moved by the piston rod, and forms a first dose setting member, the piston rod 203 is shown as a threaded rod. 第二剂量设定元件为带有内螺纹的螺母204,以与活塞杆203的外螺纹配合。 The second dose setting element is a nut with internal threads 204, 203 with the external threads of the piston rod fit. 带有孔的中空部件形成为螺母的整体部分,以用作注射按钮205,其中,所述孔用来容纳活塞杆的近端。 The hollow member with apertures formed as an integral part of the nut, to be used as an injection button 205, wherein the aperture for receiving the proximal end of the piston rod. 壳体中的销217与活塞杆中的轴向轨迹接合,从而阻挡该活塞杆,使之不能相对于壳体旋转。 The pin housing 217 and engages an axial track in the piston rod, the piston rod to block, making it impossible to rotation relative to the housing. [0067] 在要设定剂量时,在螺母204紧靠止挡件206的情况下,设备处于初始位置。 [0067] To set the dose, in the case where the nut 204 abuts against the stopper 206, the device in the initial position. 通过激活一对剂量设定键207和208中的一个来设定剂量,该剂量设定键207和208各自用于正向计数和反向计数。 Activate one dose is set by a dose setting keys 207 and 208, 207 and the dose setting button 208 for each of the forward and reverse counter counts. 设定的剂量存储于电子控制器209中,并在显示器210上显示。 Set dose is stored in the electronic controller 209, and displayed on the display 210. 只要按压下向上计数键,设定的剂量就增加,且剂量的多少会同时在显示器上显示出来。 As long as the counting up button is pressed, the set dose is increased, the number and the dose will be displayed simultaneously on the display. 如果向上计数运行太多,则可以激活向下计数键,直到设定的剂量减小至所需的大小。 If the counting up runs too, count down keys may be activated until the set dose is reduced to the desired size. [0068] 依照电子设定剂量的剂量设定元件的机械设定由电马达211执行,该电马达211 具有输出轴,该输出轴设有伸长的齿轮212,该齿轮与螺母204周围的齿213接合。 [0068] In accordance with the dose setting member of a dose setting electronic mechanical settings performed by an electric motor 211, 211 has an output shaft of the electric motor, the output shaft is provided with an elongated gear 212, gear teeth of the nut 204 and the surrounding 213 engaged. 马达可被控制顺时针或逆时针运行,并根据设定剂量由电子电路来控制以使螺母旋转。 The motor may be controlled to run clockwise or counterclockwise, and the set dose is controlled by an electronic circuit according to rotation of the nut. 通过位置读取器216来测量旋转,该位置读取器216计数经过的齿数和方向。 By measuring the position of the reader 216 is rotated, the position of the reader 216 and the count direction of passing teeth. 在剂量已设定并且注射按钮205由用户完全压下时,设置量的药物被排出。 Dose has been set and the injection button 205 is fully depressed by the user, provided the amount of medicament is expelled. 实际上,代替使用马达来设置机械激活的致动按钮,马达可用于根据设定剂量来直接驱动活塞杆。 Indeed, instead of using a motor to activate a mechanical actuating button, the motor may be used according to the direct drive piston rod to set the dose.

[0069] 根据本发明的一个方面,光源275设置用来发射光束穿过盒体的远端部,可通过壳体中的窗口来观察到光束(如果可视)。 [0069] In accordance with one aspect of the invention, a light source arranged to emit a light beam 275 passes through the distal end portion of the cartridge body, the light beam can be observed (if visible) through the window of the housing. 如图所示,设备还设有与图5所示的实施例相应的检测器276。 As shown, the apparatus is further provided with a respective detector shown in FIG. 5 Example 276. 可替换地,光导管可用来引导光穿过一部分储存室。 Alternatively, the light guide can be used to direct light through a portion of the storage chamber.

[0070] 图8A示出储存单元的另一个实施例800,该储存单元具有较大的透明窗口850,通过该透明窗口850可看到储存室,图8B-8E示出去除了带有窗口的壳体部从而露出柔性储存室860和泵组件870的实施例。 Another [0070] FIG. 8A shows an embodiment of the storage unit 800, the storage unit having a large transparent window 850, the reservoir chamber 850 may be seen through the transparent window, shown in FIG. 8B-8E out except with the window casing Example body portion thereby exposing the flexible storage chamber 860 and pump assembly 870. 图8B示出其中光导管890设置在储存室每一侧上用于将光线从单元外部引导至储存室的实施例,图8C示出其中光导管891设置在单元的端部表面上的实施例,图8D示出其中弯曲的光导管892设置成将光线从单元的侧部引导至储存室端部的实施例,以及图8E示出其中光源895设置在单元内部从而将光线引导到储存室中的实施例。 8B shows a light pipe 890 which is provided for directing light from an external unit to the storage chamber embodiment on each side of the storage chamber, wherein FIG. 8C shows a light pipe 891 is provided on the end portion of the embodiment the surface unit FIG 8D shows an example in which the curved light guide 892 is arranged to direct light from the side unit to the storage chamber ends embodiment, and FIG. 8E shows a state where the light source 895 disposed inside the unit so as to direct light into the reservoir chamber embodiment. 光导管可设置在光源和储存室之间,从而以所需的方式将光线引入储存室。 Light pipe may be disposed between the light source and the storage chamber, whereby a desired manner light into the storage chamber. [0071] 图9示出具有不同程度原纤维化的胰岛素的三个盒体,这三种程度为强原纤维化的胰岛素901,稍微轻、刚好认出原纤维化的胰岛素902,到正常的胰岛素903。 [0071] FIG. 9 shows a case with three different degrees of fibrillation of insulin, which is a strong three degrees fibrillated insulin 901, little light, just recognize fibrillated insulin 902, to the normal 903 insulin. 红色激光束905从右侧传输到左侧,但是只有在带有原纤维化的胰岛素的两个盒体中可以看到,其中, 在该两个盒体内发生光束分散。 Red laser beam 905 transmitted from right to left, but only with two box fibrillated insulin can be seen, wherein the two beam spread occurs in the case body.

[0072] 上述依照本发明的单独方面的设置可相互独立使用,并可与依照本发明的其他方面的元件结合。 [0072] In accordance with the aforementioned separate aspect of the present invention is provided may be used independently of each other, it can be combined with other elements in accordance with aspects of the present invention.

[0073] 在示范性实施例的以上叙述中,已经在本发明的原理对本领域读者清楚的程度内对不同结构进行了描述,这些不同结构提供不同部件间的机械、电和流体接触和连通,正如具有不同部件(例如,泵、储存室、能源、内存、控制器、显示器等)的所述功能的装置一样。 [0073] In the above described exemplary embodiment, has different structure is described in the principle of the invention to those skilled apparent to the reader the extent of these different structures providing mechanical, electrical and fluid contact and communication between the different members, as the apparatus having a function of different components (e.g., pumps, storage chamber, energy, memory, control, display, etc.) of the same. 考虑了不同部件的详细结构和说明,由本领域技术人员按照本说明书的思路执行的正常设计程序的目的在本说明书中进行了阐述。 Consider the detailed structure and description of the different components, set forth in the present specification by the object of a normal design procedure performed by the skilled person along the lines of this specification.

Claims (12)

  1. 一种药物输送设备(650),其包括:-容纳液体药物的储存室(660),-排出组件(670),其用于在使用情况下从储存室中排出药物,-光管(690),其具有光线入口和光线出口,用于引导该药物输送设备外部所产生的光线进入所述储存室(660)中,以及-透明区域(452),其允许用户检查储存室的一部分,以由此检查光通过药物的传输特征。 A drug delivery device (650), comprising: - receiving the liquid medicine storage chamber (660), - discharge assembly (670) for discharging the medicament from the storage chamber in use, - the light pipe (690) , having a light inlet and a light outlet, for directing light from the external medication delivery device produced into the storage chamber (660), and in - a transparent area (452), which allows the user to check a portion of the storage chamber to the this inspection light transmission characteristics of the drug through.
  2. 2. 如权利要求l所述的药物输送设备,其特征在于,所述光管以非直线的方式引导光线。 2. The drug delivery device according to claim l, wherein said light pipe to direct light non-linear manner.
  3. 3. 如权利要求1所述的药物输送设备,其包括与光线入口相连的可见光产生源。 Drug delivery device according to claim 1, comprising an inlet connected to the light source to produce visible light.
  4. 4. 如权利要求1所述的药物输送设备,其特征在于,设置一个或多个光管,以照亮储存室的内部。 4. The drug delivery device according to claim 1, characterized in that, provided one or more light tubes to illuminate the interior of the storage chamber.
  5. 5. 如权利要求1所述的药物输送设备,其特征在于,光管适于引导光束通过储存室。 5. The drug delivery device according to claim 1, wherein the light pipe is adapted to direct the beam through the storage chamber.
  6. 6. 如权利要求l-5中任一项所述的药物输送设备,其特征在于,储存室(660)包括第一和第二柔性箔片部件,该两个柔性箔片部件密封在一起,从而形成袋形结构的储存室,该袋形结构限定总平面,该储存室具有圆形边缘部分,光线被引导通过该圆形边缘部分。 6. l-5 The drug delivery device of any one of the preceding claims, characterized in that the storage chamber (660) comprises a first member and a second flexible foil, the two flexible foil members sealed together, thereby forming a bag-like structure storage chamber, the bag-like configuration defining a general plane, the reservoir chamber having a rounded edge portion, the light is directed through the rounded edge portion.
  7. 7. 如权利要求5所述的药物输送设备,其特征在于,排出组件包括泵,所述泵具有在使用情况下与储存室流体连通的入口(580)。 7. The drug delivery device according to claim 5, wherein the expelling assembly comprises a pump having an inlet (580) in use in fluid communication with the storage chamber.
  8. 8. 如权利要求1-5中任一项所述的药物输送设备,其特征在于,储存室为圆柱形部件(201)的形式,其具有可滑动地设置在该圆柱形部件(201)内的活塞。 8. The drug delivery device according to any one of claims 1-5, characterized in that the storage chamber in the form of a cylindrical member (201) having (201) within the cylindrical member slidably disposed pistons.
  9. 9. 如权利要求8所述的药物输送设备,其特征在于,排出组件包括活塞致动器、用于控制该活塞致动器的电子控制器以及能源。 9. The drug delivery device according to claim 8, wherein the discharge assembly includes a piston actuator, for controlling the piston actuator electronic controller and energy.
  10. 10. 如权利要求1-5中任一项所述的药物输送设备,其特征在于,光管适于使入射光线偏转,从而将其引导至储存室。 10. The drug delivery device according to any one of claims 1-5 claims, characterized in that the light pipe is adapted to deflect the incident light, so as to guide it to the storage chamber.
  11. 11. 如权利要求l所述的药物输送设备,还包括: -下表面(12),其适于以朝向注射对象皮肤的方向应用, -经皮设备,其适于剌穿注射对象的皮肤, -其中,该经皮设备设置成与储存室流体连通。 11. The drug delivery device according to claim l, further comprising: - a lower surface (12) which is adapted to the injection direction toward the skin of the subject application, - transdermal device adapted pierces the skin of the injection target, - wherein the transcutaneous device arranged in fluid communication with storage chamber.
  12. 12. 如权利要求11所述的药物输送设备,其特征在于,排出组件包括剂量设定部件(171)和用户致动部件(175),其中,剂量设定部件(171)可移动到选择的设定位置,该位置表示要输送药物的设定剂量,该用户致动部件(175)允许排出设定的剂量。 12. The pharmaceutical as claimed in claim 11, wherein the delivery device, wherein the discharge assembly includes a dose setting member (171) and a user actuation member (175), wherein the dose setting member (171) movable to selected setting position which indicates the set dose of medication to be delivered, the user actuation member (175) allowing the set dose discharged.
CN 200580029490 2004-09-02 2005-09-01 Medical device adapted for detection of drug condition CN101010112B (en)

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US20090216194A1 (en) 2009-08-27
EP1791581A2 (en) 2007-06-06
WO2006024650A3 (en) 2006-05-11

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